Class III
Terminated
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- January 21, 2021
- Posted
- February 10, 2021
- Recall Number
- D-0247-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 46,479 bottles
- Firm Location
- Baltimore, MD, United States
Reason for Recall
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Distribution
Nationwide
Lot / Code Info
Lot # A906423, exp. date Nov 2021.
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